Penumbra Neuron 5F Select Catheter Recall
The Food and Drug Administration (FDA) and Penumbra Inc. notified healthcare workers that they had begun to initiate a Class I recall of the Neuron 5F Select Catheter on May 29, 2009. This catheter is used to remove blood clots or foreign objects from blood vessels. It was manufactured in late May and distributed through June 12.
The FDA and Penumbra Inc. have stated the reason for the recall as a manufacturing error. According to the FDA medical device recall announcement, the Neuron 5F “may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death.”
The FDA further states that all defective catheters were returned to Penumbra Inc. and destroyed.
A Class I recall is the most serious type of recall the FDA announces. This means there is a reasonable probability that the product, like the Penumbra Neuron catheter, will cause injury or death.
The FDA has asked healthcare professionals and consumers to report adverse reactions or other problems with the Neuron 5F Select Catheter to the FDA’s MedWatch Adverse Even Reporting Program. You may also contact Penumbra, Inc. at 510-618-3223.
If you or your loved one has been injured by the Neuron 5F Select Catheter or another defective medical device, please contact the experienced personal injury attorneys at Schlichter, Bogard & Denton. We serve clients nationwide.